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Cytokinetics宣布Aficamten在阻塞性肥厚型心肌病患者中的关键性3期临床试验SEQUOIA-HCM取得积极结果

Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy

GlobeNewswire 等信源发布 2023-12-27 20:30

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Statistically Significant and Clinically Meaningful Increasein Primary Efficacy Endpoint at 24 Weeks of Treatment; Improvement Consistent Across All Prespecified Subgroups Statistically Significant and Clinically Meaningful Improvements in All Secondary Endpoints No Instances of Treatment Interruptions Due to Low LVEF Company to Host Conference Call and Webcast Today at 8:30 a.m.

治疗24周时主要疗效终点有统计学意义和临床意义的增加;所有预先指定的亚组的改善一致所有次要终点的统计学显着和临床意义的改善没有因LVEF低而导致治疗中断的情况公司今天上午8:30主持电话会议和网络广播。

Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

加利福尼亚州南旧金山东部时间,2023年12月27日(环球通讯社)--Cytokinetics,Incorporated(Nasdaq:CYTK)今天宣布,红杉-HCM(Aficamten在HCM中的阻塞影响的安全性,有效性和定量理解)的阳性结果,这是Aficamten在症状性梗阻性肥厚型心肌病(HCM)患者中的关键3期临床试验。

The results of SEQUOIA-HCM show that treatment with aficamten significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by a least square mean difference (95% CI) of 1.74 (1.04 - 2.44) mL/kg/min (p=0.000002).

SEQUOIA-HCM的结果显示,与安慰剂相比,用阿非卡姆汀治疗显着提高了运动能力,通过心肺运动试验(CPET)测量的峰值摄氧量(pVO2)增加了1.74(1.04-2.44)mL/kg/min(p=0.000002)。

The treatment effect with aficamten was consistent across all prespecified subgroups reflective of patient baseline characteristics and treatment strategies, including patients receiving or not receiving background beta-blocker therapy. Statistically significant (p<0.0001) and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints, including Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at weeks 12 and 24, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class at weeks 12 and 24, change in provoked left ventricular outflow tract gradient (LVOT-G) and proportion <30 mmHg at weeks 12 and 24,.

在反映患者基线特征和治疗策略的所有预先指定的亚组(包括接受或不接受背景β受体阻滞剂治疗的患者)中,阿非卡姆汀的治疗效果是一致的。在所有10个预先设定的次要终点,包括第12周和第24周的堪萨斯城心肌病问卷临床总结评分(KCCQ-CSS),第12周和第24周纽约心脏协会(NYHA)功能分级≥1级改善的患者比例,也观察到统计学显着(p<0.0001)和临床意义上的改善,在第12周和第24周,激发的左心室流出道梯度(LVOT-G)和比例<30 mmHg的变化,。